Pharmacy Compliance: Regulations and Guidelines

• The material is designed to guide understanding of pharmacy skills within a regulatory context.
• Includes regulatory compliance, Medicare/Medicaid, the Joint Commission, functional areas, USP standards, agency roles, internal oversight, non-sterile compounding, suspensions, creams/ointments/pastes/capsules, quality and process improvement, drug distribution, drug control and diversion, DEA expectations, risk points, drug shortages, NECC tragedy, USP 800, and NIOSH.

Regulatory Environment and Compliance

• Compliance means meeting requirements of standards, laws, rules, regulations, policies, or contracts.
• Compliance is important and has serious potential consequences.
• These consequences include penalties, accreditation status, publicity and patient safety/quality of care.
• Standard: a measure, norm, or model for evaluations.
• Ex: residency accreditation standards.
• Law: commands backed by sanctions from a sovereign power.
• Ex: speed limits.
• Rule: principle or regulation governing conduct for compliance and discipline like Board of Pharmacy rules.
• Regulation: rules by a government or authority to control actions like Board of Pharmacy rules.
• Policy: formulated by management for decision-making and uniformity, such as attendance policies.
• Contract: written or spoken agreement, enforceable by law, relating to employment, sales, or tenancy, such as purchasing agreements.

Medicare and Medicaid Services

• A federal agency covering ≈40% of healthcare.
• Establishes regulations.
• Pays only if conditions of participation and quality standards are met.
• The Joint Commission (TJC) and Det Norske Veritas (DNV) are authorized accrediting bodies.

The Joint Commission

• Founded in 1951 by surgeons to reduce infection rates in hospitals.
• It is a non-profit, independent organization.
• The mission is to improve safety and quality by setting standards of care.

Functional Areas & Standards of Care

• Includes 270 standards across 19 areas with performance elements, and is continuously revised.
• Medication Management Standards include 21 standards and 143 specific performance elements.
• Certification programs are separate, voluntary, and optional.
• National Patient Safety Goals include 12 goals in 8 categories, including 3 medication-related goals.
• Eventually goals can become standards.

Survey Process

• Occurs every 3 years with a team of 3-10 surveyors.
• Surveyors may be physicians, nurses, or administrators.
• Surveys are unannounced and educational.
• "Tracer" method follows a patient's course of care.
• Non-compliance results in Requirement for Improvement (RFI).
• SAFER matrix is used for risk evaluation.
• It prioritizes important areas for action.

USP (United States Pharmacopeia)

• An independent, nonprofit scientific organization focused on ensuring trust in the supply and quality of medicines.
• Sets quality and purity standards.
• USP 795 covers non-sterile compounding.
• USP 797 covers sterile compounding.
• USP 800 covers hazardous drug handling and compounding.

Agency's Roles with UMH

• The Drug Enforcement Administration (DEA) and UMH had events in 2013 that led to oversight committee formation and policy changes.
• These changes included a $4.3 million fine.
• There were remediation efforts, external audits, and HR requirements.
• The FDA and UMH had an ophthalmic event in 2016.
• This led to facilities construction costs, compliance team formation, personnel training, policies, and procedure development.

ASHP (American Society of Health-System Pharmacists)

• Established in 1942.
• Harvey Whitney was the Chief Pharmacist and the first chairman of ASHP
• ASHP has best practices for policy statements, guidelines, statements, and tech assistance bulletins

Internal Oversight

• Oversight is provided by the univeirs, hospital, department, and policies.
• This includes the Compliance department and P&T committee.
• Also includes the Executive committee on clinical affairs (ECCA), Patient safety and quality committees and Internal auditors

Internal Audits

• Important for ensuring compliance.
• Should be systematic and proactive.
• Prioritization of legal requirements, accreditation standards, and internal policies is needed.

Non-Sterile Compounding

• Introduction and History of Non-Sterile Compounding covers laws, policies and procedures.
• The first United States Pharmacopeia (USP) was established in 1820, which created baseline for pharmacy regulation.
• It was missing compounding formulas, procedures, techniques, and drug purity consideration.
• The first National Formulary paved the ground for national standards of chemical purity, strength, and quality
• Lacked legal binding power therefore had limited uniformity.
• The 1906 Food, Drug, and Cosmetic Act (FD&C) made it law for all drugs to meet USP and NF standards.
• The 1938 FD&C Act added misbranding and adulteration to the language.
• The FDA was given the power to regulate labeling and packaging of drugs.
• 1962 Kefauver-Harris Amendments added Good Manufacturing Practices (GMP) enforced by FDA, and required Marketing FDA approval.
• 1975 Publication of Pharmacopeial Forum gave public guidelines prior to implementation and allowed public comments on upcoming guidance documents.
• 1997 FDA Modernization Act (FDAMA) and USP <1161> Pharmacy Compounding Practices recognized the need for traditional compounding of medications for patients with unique needs.
• It offered support for traditional compounding via enforceable guidelines.
• 2000 1st USP<795> Pharmaceutical Compounding - Nonsterile Preparations has been updated & revised multiple times.
• The current enforceable version is 2014 USP <795>.
• The 2014 USP Increased the quality of non-sterile compounding and lead way to better practices for sterile compounding.
• Enacted in 2013, the Drug Quality and Security Act (DQSA) resulted from the New England Compounding Center Meningitis Outbreak (where steroid suspensions were NOT sterile).
• Furthermore, it legislated greater oversight over compounding pharmacy.
• Compounding requirement now belongs as part of CMS conditions of participation which increases accreditation of compounding pharmacies.

USP <795> Pharmaceutical Compounding: Non-Sterile Preparations

• Covers categories of compounding, responsibilities of compounder, and compounding process
• Covers compounding facilities, equipment, and component selection/handling/storage
• Includes stability criteria and beyond use dating (BUD), Packaging/Drug Preparation Containers, and Compounding Documentation
• Concerns Quality Control, Patient Counseling, Training, and Compounding for Animal Patients

Proposed Chapters USP <795> and <797>

• BUD includes extension of BUDs based on stability indicating assays and tests
• <797> does NOT allow for extension desire validated tests, so there is removal of Alternative Technology Provision for <797>
• There is now applicability to Veterinary practitioners.

Beyond-Use-Date for Oral and Topical Non-Sterile Compounded Products

• Non-preserved aqueous dosage form (Oral liquid, Cream, Gel etc) has a BUD of 14 days and requires Refrigeration.
• Preserved aqueous dosage form has a BUD of 35 days and requires controlled room temperature or refrigerator.
• Oral liquids (non-aqueous) has a BUD of 90 days and require controlled room temp or refrigerator
• Other nonaqueous dosage forms (Ointment, Paste, Capsule) has a BUD of 180 days and requires controlled room temperature or refrigerator

Suspensions

• Two-phased system of a finely divided solid dispersed in a solid, liquid, or gas
• A good suspension contains drug uniformly dispersed throughout the vehicle.

Suspension Terminology

• Oral suspensions are liquid preparations in which solid particles of the active drug are dispersed in a sweetened, flavored, and sometimes viscous vehicle.
• Topical suspensions are liquid preparations with solid particles dispersed in a suitable liquid vehicle to be applied to the skin.
• A Solution is liquid preparation with 1+ drug substances dispersed in a solvent, which contains no flavoring, sweeting, or coloring agents.
• Trituration is pulverizing a powder/tablet to reduce particle size using a mortar and pestle.
• This is done to increase dissolution/suspending of the API.
• Levigation is wetting and pulverizing of dry/wet component.
• This involves adding wetting agent to powder for even dispersion of newly formed past into base liquid like Glycerin, mineral oil, alcohol, and PEG.

Suspension Components & Preparation

• Should contain a suitable vehicle with Insoluble particles, Liquid medium, Surfactant, Viscosity enhancer, and a preservative.
• First, obtain uniform, small particles of the drug.
• Second, the active insoluble material should be thoroughly wetted before it is mixed with the vehicle.
• Third, combining drug and wetting agent to form a thick paste and then adding the vehicle with constant stirring
• Hydrophilic Wetting agent should use water-miscible liquids, for example glycerin
• Hydrophobic Wetting agent should use nonpolar liquids or Use of surfactant, for example Benzalkonium chloride

Suspension Quality Control, Packaging & Counseling

• Evaluate weight and volume, extent of settling, ease of dispers, appearance, odor and pour
• Use tight containers with a large opening that is large enough to easily pour a viscous liquid
• Sufficient headspace should be allowed for ease of shaking in either Room temp or refrigerated
• Always shake the suspension before taking or applying it.
• The suspension should be shaken vigorously or mix using rolling action, and users should be counseled on proper storage and method for measuring doses.
• Less susceptible to chemical degradation than other solutions, but if water is present, suspensions have a short BUD

Creams

• Opaque, soft or thick solids or liquids, where medications are dissolved or suspended in water-soluble or vanishing cream bases.
• Creams may be water-in-oil (w/o) or oil-in-water (o/w).
• Applied topically, rectally, and vaginally for moist, weeping lesions (drying effect).
• Only a thin film should be applied; do not wash the area for a few hours and can remove with warm water and soap.
• Stability: Observe for emulsion breakage, crystal growth, shrinkage from water loss, microbial contamination.

Ointment

• Semisolid preparations, applied externally to skin/membranes, soften/melt at body temperature, spread easily.
• Applied topically, rectally, and ophthalmically.
• Only a thin film should be applied and do not wash the area for a few hours.
• Relatively stable, but less stable if water is present and only stable for about 30 days.

Pastes

• Stiff, thick ointments that do not flow at body temperature.
• Pastes are >20% solids, protective coating for areas to which they are applied.
• Applied topically for area in need of protection.
• Place on area but do not rub in or remove unless indicated.

Capsules

• Dosage forms in which units of doses of powder, semisolid, or liquid drugs are enclosed in either a soft or hard envelope.
• Hard gelatin are prepared to release the drug rapidly or over a predetermined time
• Soft gelatin are used for Agreeable presentation, conceal taste, portability, light weight, and rapid drug release via Oral or Rectal/Vaginal administration

Capsule Quality Control

• Read label on bottle at least 3 times and record necessary information and weigh groups of capsules.
• A patient may be advised to place the capsule on the back of the tongue before drinking a liquid water or may also place the capsule in warm water for a few seconds before taking, which easily makes it slide over the mucous membranes
• Another method is TSP of flavored candy gel placed/swished in the mouth upon which the capsule is placed and swallowed
• Small capsules can be used or even use a liquid preparation

Capsule Size & Stability

• Eight sizes of capsules are generally used.
• Capsule capacity depends on density and characteristics of the powder
• Generally used to encapsulate between 65-1000mg of powdered.
• Consider patient's ability to swallow.
• Capsules are stable as long as protected from moisture and heat.
• Beyond-use dates are set according to the state board of pharmacy or local jurisdiction requirements with the state to which the compounded medication is to be.

Pharmaceutical Compounding Terminology

• Spatulation: incorporate individual products into a homogeneous product
• Levigation: wetting/pulverizing of a dry component for incorporation into cream, ointment, or paste
• Geometric Dilution: incorporates a smaller quantity of a substance into a larger quantity where a mixing is required on each part until equal mixing occurs
• Mixing is accomplishable by use of an oinment slab or pestle/mortar

Quality and Process Improvement

• Healthcare quality relates to how health services increase desired health outcomes that align with current knowledge.
• This is important as it drives patient safety, rewards pharmacists for quality, lowers costs, increases reimbursement.
• Students need to understand upcoming healthcare changes, and these changes include pharmacist roles.
• Safety is a crucial component of quality and a first obligation as health professionals "to do no harm".
• However, there are 1-2 serious errors/week in community pharmacy; 7,000 deaths/yr are due to ADEs in hospitals.

Health Care Quality Measures

• Structural Measures pertain to adequacy and organizations- for example the Hospital's percentage of board-certified clinicians
• Process Measures pertain to methods and policies that allow for the provision of care- for example the performance screening mammograms
• Out-Come Measures pertain to measures of quantity and quality of life- for example- the risk-adjusted 30-day mortality rate following hospital discharge

Process Improvement

• Quality Planning: identifying measures to track, comparing them to performance, and assigning key goals
• Quality Control: performing by defined policies and tracking performance over time
• Quality Improvement: assessing current performance level to contribute to current contributions

Hospital Acquired Infections vs. Chronic Illness Treatment

• Hospital Acquired Infections include CLABSI, HAP/VAP and surgical site infections.
• Chronic Illness Treatment/Prevention includes adherence to GDMT, patient adherence, smoking cessation, and lowered hospital admit/readmit and/or mortality rate

Medication Quality: Utilization Vs Errors

• Medication Utilization involves controlled substances audit and cost analysis.
• Medication Errors include preventable ADRs, in addition to the inclusion wrong dose/drug/route/patient

Quality Improvement Tools

• LEAN focuses on eliminating waste and maximizing productivity, including overproduction, lag-time, transport, motion, over-processing, inventory, and defects
• Six Sigma (focuses on reducing process variation and errors) entails a process measure for performance, analysis erros to improve and control the process
• Root-Cause-Analysis- this process begins at point of an event upon which to work backwards to identify the cause for failure

Stakeholders Responsible for Improving Healthcare Quality

• Include Government via CMS (largest health insurer) or Non Gov insurers (HMO/ PPO)
• CMS relies on the Joint Commission to delegate what is quality and is often an accrediting body
• State regulatory boards exist to protect the public with political appointees who have little training- understaffed and little political power
• Regulatory agencies like The Joint Commission can evaluate the performances of entities or set patient goals for safety which is ultimately to based on national standards of care
• Additional Quality organizations can provide support

Pharmacist's Role in Healthcare Quality

• Provide medication and order expertise, target concurrent screening for patients, and document contraindications for the purpose of vaccine ordering
• CMS recognition, and a pharmacists ability to document is acceptable
• Healthcare quality can improve service results if they are of unsafe care
• Reimbursement should be performance based on performance factors

Healthcare Reiumbersment

• Reimbursement is true pay is performance and is quality base
• Reimbursement is Pre-established targets of deliverable
• This model entails 4 "domains" for patient outcome or person engagement for which the data is derived from Measure or dimension score of achievement in comparison to other hospitals

Health System Drug Distribution: Order

• Order- Prescribers must confirm allergies or consider high or low relevant labs for DDIs and/or dose duplications
• System wide, computerized order systems improve communication or reduce errors. Additionally, there is increase cost in work arounds.

Health System Drug Distribution: Verification

• Verification- A pharmacist is expected to ensue for the correct indication of a drug for the appropriate route to manage contraindications, or duplications for the appropriate duration and dose

Health System Drug Distribution: Dispensing

• Dispensing: A pharmacist should consider single unit package from that are ready to use, with enough supply for the time period to avoid excess waste or drug billing

Health System Distribution Delivery Type

• "Decentralized" supply can be dispensed in automated cabinets such as analgesics or emergency medication where as a "centralized" supply means it is dispensed by the pharmacy

Administration of Medications

• Barcode Medication Administration (scanning barcodes to confirm correct drug/pt) can contribute to 93% of error reduction
• Smart pumps can be used to program the rate or alert for allergies or ADRs

Error Reporting

• Tool in an effort to reduce errors, provide accountability, and promote patient safety
• Drug Distribution: involves physical transfer from area to pharmacy for medication administration to a pt

Drug Distribution Systems

• Central inpatient pharmacy supplies all patients in a hospitals.
• The formulary is often determined by the hospital and its P&T committee
• Storage and handling should occur in a secure location as high alert and controlled drugs should be tracked

Sterile Compounding

• Technicians and pharmacist must have training in aseptic style and volume dilution
• A syringe pullback will mark what volume of the drug was used
• Automation helps ensure precise adminixtures
• Gravimetric verification utilizes density to confirm accuracy

Compounding Documentation

• "Image capture" captures visual steps in lot images
• Commercially unavailable products are non-sterlie
• Formulary will require instruction of compounding for specific preparations
• Where is an order in the event of a mishap/deviation- this involves transfer of lawful distribution

Diversion of Controlled Substances

• Unlawful use of controlled substances
• Stealing or Misuse
• Puts carriers at risk
• This can be performed due to "complacency" or by "falsifying and/or tampering" of records

Detecting Diversion

• Signs of diversion includes: absences and changes in moods
• DEA expectations assures accountability while violations incurs monetary sanctions or even legal

Responsibilities for Safe Use of Controlled Substances

• Impatient care from impaired providers
• A loss of employment or substance/license

Key Safety Strategies

• Take responsibility through "telling stories" and "reporting non/compliance
• Follow protocol according to security or compliance.
• The point of "CSDDP " or controlled substance prevent and response to safety of community and patients is the management of HR through internal controls and tracking

Risk in Dispensing

• Includes situations products have similar appearance in prep where overdoses has happened.
• Additionally, in pharmacy, pads have been forged with fraudulent writing

Inpatient "Risk Areas"

• OR settings
• Hospitals

Drug Shortages

• Definition: period of time with projected drugs may have exceeded supply
• Happens when all manufacturers meet total needs
• Types: Formulation of pre, limited and/or a complete lack there of

Shortage Risk Factors

• Quality or Delays or Disasters
• Changes happen or are more cyclical
• Manage sites This leads a decline in morale for patients of quality versus ethical

Management of Drug Shortages

• Have an alternative to a therapeutic option and a list and/or discussion panel
• Meet to discuss subject concerns

Strategies to Mitigate Loss

• Communicate and gather data to consider purchasing alternatives where technology helps alter change/ration decisions
• Focus on the current population with alternatives

Key Factors to Consider

• Differences in product in comparison to patient
• Considers various avenues

NECC Tragedy Review

• Essential for patients who may need it
• Can't prepare individualized patients
• USP only chapter over worker Safety
• New England has a Meningitis outbreak which led to acts for greater over site by 2013

Just Culture

• Review if there was a Substitution
• Test for intent, that there was no safety compromise from either employee

Medication Errors

• OSHA sets handling standards that will protect healthcare works or hazardous medication from spills while CDC reports on setting and handling drugs

Minimizing Risk

• Use various eningeerign control and PPEs
• Have guidelines for handing hazadous drugs
• Clean "c-peccs"

Standards for Proper Staff Care and Safety

• Provide guidelines for those touching Haz Drugs, to reduce risk there if a HD and anti-neoplastic ingredient
• A containment has no air because there is no exposure, is less safe than engineering to protect the staff

Best Protection

• Elimination

Explore key aspects of pharmacy compliance, including the role of regulations, internal guidelines, and contracts. Learn to identify compliance violations related to handling controlled substances and patient information.